Side Effects of Vascular Endothelial Growth Factor (VEGF) and Epidermal Growth Factor Receptor (EGFR) Directed Therapy (Mabtornib)
This study is currently recruiting participants.
Verified January 2013 by University Medical Centre Groningen
Sponsor:
University Medical Centre Groningen
Information provided by (Responsible Party):
J.A. Gietema, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00657098
First received: April 8, 2008
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy.
| Condition |
|---|
|
Metastatic Malignancies |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors |
Resource links provided by NLM:
Further study details as provided by University Medical Centre Groningen:
Primary Outcome Measures:
- Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors. [ Time Frame: after 3 and after 6 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- DNA analysis [ Time Frame: day -7 till day -1 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum Plasma Urine DNA
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Observation |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who will be treated with angiogenesis inhibitors or EGFR inhibitors
Criteria
Inclusion Criteria:
- Patients who will start with an angiogenesis inhibitor or EGFR inhibitor
- Concomittant chemotherapy, immunotherapy or radiotherapy is allowed
- Age above 18 years at start of treatment
- Willingness to give written informed consent
Exclusion Criteria:
- Unable to give written informed consent
- Age under 18 years
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657098
Contacts
| Contact: Sjoukje F Oosting, MD | +31 50 3616161 ext 12821 | s.oosting@umcg.nl |
| Contact: Jourik A Gietema, MD | +31 50 3616161 ext 12821 | j.a.gietema@umcg.nl |
Locations
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9700 RB | |
| Contact: Jourik A Gietema, MD, PhD +31 50 3616161 ext 12821 j.a.gietema@umcg.nl | |
| Contact: sjoukje F. Oosting, MD +31 50 3616161 ext 12821 s.oosting@umcg.nl | |
| Principal Investigator: Jourik A Gietema, MD, PhD | |
| Sub-Investigator: Sjoukje F. Oosting, MD | |
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
| Principal Investigator: | Jourik A Gietema, MD/PhD | University Medical Center Groningen, The Netherlands |
More Information
No publications provided
| Responsible Party: | J.A. Gietema, Principal Investigator, University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT00657098 History of Changes |
| Other Study ID Numbers: | 2007/203 |
| Study First Received: | April 8, 2008 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by University Medical Centre Groningen:
|
Side effects Angiogenesis inhibitors Epidermal growth factor receptor inhibitors Tyrosinekinase inhibitors |
Additional relevant MeSH terms:
|
Neoplasms Mitogens Angiogenesis Inhibitors Endothelial Growth Factors Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013